NCT00955162

Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")

A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries. Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals. Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.

Conditions

• Opioid Dependency

Interventions

Type	Name	Description
DRUG	Buprenorphine (Subutex)	Sublingual tablet
DRUG	Buprenorphine/naloxone (Suboxone)	Sublingual tablet

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-05-01
• Completion: 2011-05-01
• First posted: 2009-08-07
• Last updated: 2012-11-30

Locations

20 sites across 1 country: France